Status:
RECRUITING
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goa...
Detailed Description
This is a Phase 3, randomized, open-label, multicenter trial evaluating quabodepistat-containing regimens for rifampicin-resistant/multidrug-resistant (RR/MDR) pulmonary tuberculosis (TB). The study ...
Eligibility Criteria
Inclusion
- Age ≥14 years
- Body weight ≥30.0 kg
- Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
- Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
- Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
- Chest radiograph consistent with active TB disease
- Able to provide sputum sample
- Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
- Willing to have HIV test (unless previous positive result confirmed)
- For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load \<200 copies/mL, and CD4 count \>100 cells/mL
Exclusion
- Known/suspected resistance to BDQ, PMD, LZD, or QBS
- Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
- Severe extrapulmonary TB
- Abnormal laboratory values: ALT/AST \>2.5×ULN, Total bilirubin \>1.5×ULN, eGFR \<60 mL/min/1.73m², Hemoglobin \<8 g/dL, Platelets \<100,000 cells/mm³, WBC \<2.0×10⁹/L, ANC \<1000 cells/μL, and HbA1c \>9.0%
- Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment
- Co-enrollment in other therapeutic trials
- QTcF \>450 msec (males) or \>470 msec (females)
- Clinically significant cardiovascular disorders
- Bleeding disorders
- Conditions interfering with X-ray or sputum assessment
- Drug allergies/hypersensitivity to study medications
- Pregnancy or breastfeeding
- Positive drug screen (case-by-case assessment for some substances)
- Serious mental disorders
- Karnofsky score \<60
- BMI \<16.0 kg/m²
- Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
- Pulmonary conditions other than TB (silicosis, fibrosis)
- Active SARS-CoV-2 infection
- Use of prohibited medications
- Blood/plasma donation within 30 days
- Current use of herbal remedies or traditional medicines
Key Trial Info
Start Date :
October 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2028
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT07209761
Start Date
October 16 2025
End Date
September 29 2028
Last Update
December 10 2025
Active Locations (34)
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1
Capital Medical University - Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101100
2
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518112
3
Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)
Wuhan, Hubei, China, 430032
4
The Second Hospital of Nanjing
Nanjing, Jiangsu, China, 210003